Psychological Counseling Program for Alzheimer's Patients' Caregivers (PsychoCP)

December 24, 2024 updated by: Aydan Akkurt Yalçıntürk

The Effect of Psychological Counseling Program (PsychoCP) for Alzheimer's Patients' Caregivers on Perceived Stress, Psychological Well-Being and Caregiver Burden

Purpose: To investigate the effects of a psychological counseling program (PsychoCP) applied to caregivers of Alzheimer's patients on perceived stress, psychological well-being and care burden.

Design: The study will be conducted in a pre-test post-test control group, randomized controlled experimental research design.

Method: The study is planned to be carried out in Bağcılar Municipality Vefahâne Life Center, Antalya Alzheimer Patients and Patient Relatives Meeting Center and Osmaniye Family and Social Policies Directorate. The sample of the study will consist of 80 caregivers. They will be assigned to intervention (n=40) and control groups (n=40) by randomization.

Hypotheses Hypothesis1: The perceived stress level of caregivers who received PsychoDP is lower than those who did not receive PsychoCP.

Hypothesis2: The psychological well-being levels of caregivers who received PsychoDP are higher than those who did not receive PsychoCP.

Hypothesis3: The care burden of caregivers who received PsychoDP is lower than those who did not receive PsychoCP.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Providing informal care to an individual with mild or moderate Alzheimer's disease
  • Being a primary caregiver
  • Providing care to the patient for at least six months
  • Providing care to the patient for at least six hours per day
  • Being literate
  • Being able to speak and understand Turkish
  • Being 18 years of age or older
  • Being willing and able to participate in the study

Exclusion Criteria:

  • Not being able to understand questions and express ideas
  • Having a psychiatric disorder
  • Not receiving any therapy services during the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: PsychoCP
Other: Psychological Counseling Program

The Psychological Counseling Program consists of 8 sessions for caregivers of individuals diagnosed with Alzheimer's.

Aims of the sessions:

Session 1: Introduction, Collection of pretest data Session 2: It is aimed to inform Alzheimer's caregivers about the disease and its symptoms.

Session 3: It is aimed to strengthen caregivers' coping skills. Session 4: It is aimed to inform Alzheimer's patients about daily care practices.

Session 5: It is aimed to provide information to Alzheimer's caregivers about coping with stress.

Session 6: It is aimed to provide information about medical and financial support that individuals diagnosed with Alzheimer's and their relatives can receive in the region they live.

Session 7: It is aimed to conduct Q&A sessions on the problems that caregivers bring.

Session 8: Collection of posttest data Sessions will be completed in 8 weeks, one day a week. Each session is planned to last approximately 60 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived Stress Level
Time Frame: Two months
Perceived Stress Scale: It was developed to measure the stress level of specific situations in individuals' lives. This scale consists of 14 items and is evaluated by participants on a 5-point Likert-type scale ranging from "never (0)" to "very often (4)". The score range of the scale is 0-56. High scores obtained from the scale indicate that the individual's perceived stress level is high.
Two months
Psychological Well-being Level
Time Frame: Two months
Psychological Well-being Scale: It is a scale that evaluates the psychological well-being of an individual. The items of the scale are rated between 1 and 7 as strongly disagree (1) and strongly agree (7). The minimum score is 8 and the maximum score is 56. An increase in the score value indicates that the person has many psychological resources and strengths.
Two months
The Burden of Caregiving
Time Frame: Two months
Zarit Caregiver Burden Scale: The scale is used to measure the stress of caregivers. It contains 22 Likert-type statements. The statements range from zero to four as never (0), rarely (1), sometimes (2), quite often (3), almost always (4). A minimum of 0 and a maximum of 88 points can be obtained from the scale. As the score value increases, the stress experienced by the caregiver also increases.
Two months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aydan Akkurt Yalçıntürk

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 15, 2025

Primary Completion (Estimated)

April 15, 2025

Study Completion (Estimated)

August 15, 2025

Study Registration Dates

First Submitted

December 24, 2024

First Submitted That Met QC Criteria

December 24, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 24, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20122024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alzheimer Disease

Clinical Trials on Psychological Counseling Program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe